BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE

    MDR report key: 20323355 · Received September 27, 2024

    Report

    Report Number
    3012307300-2024-10172
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 12, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586032370
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER SAMPLES NOR PHOTOS WERE PROVIDED FOR ANALYSIS. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 6012368 WAS REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT FAULT OCCURRED DURING INFUSION (NEARING END OF INFUSION). PER REPORTER, THE AIR IN LINE ALARM WAS TRIGGERED BEFORE INFUSION WAS TO BE COMPLETED. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ALARM. THE EVENT INVOLVED WITH A CADD-SOLIS PUMP AND TUBING. THE CASSETTE AND TUBING CONTAINED CHEMOTHERAPY. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492369 CADD CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 6012368 10610586032370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown